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gy66 replied to the topic Discussion Topic: Brand new biomaterial in the forum Pre-clinical Device Development 6 years, 9 months ago
To begin, I believe before running any type of test, determining the molecular compound, as well as the intended application, of the material is the top priority. For example, titanium, certain ceramics, and synthetic polymers can all be biocompatible but won’t all necessarily be appropriate for multiple biomedical applications. (e.g. titanium is best suitable for dental implants due to their osseointegration properties, ceramics are best suitable for bone-related medical solutions, etc). Whether or not this can be determined, a good course of action to test this new material would have to involve ex-vivo experiments. Observing the degradation of the material over time in different tissue environments, for instance, would be crucial in determining whether or not this material can last in a human body without degrading. If it were to be assumed that this material is meant to degrade overtime, then examination of the resulted particles and determining if they are harmless throughout the entire body would have to be made. If the molecular composition of the material can be determined and ex-vivo tests have been made, en-vivo tests should naturally be made if deemed plausible. This will provide a great amount of information that ex-vivo tests cannot provide. The properties that can be determined through these tests include the Carcinogenicity, Immunogenicity, Toxicity, and Teratogenicity of the material.